The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting.
Treatment with tofacitinib appears to have little impact on extraintestinal manifestations (EIMs) in patients with moderate to severe ulcerative colitis (UC) and might even improve them, according to an analysis of the OCTAVE program. Findings were presented at the 2019 AIBD Annual Meeting in Orlando, Florida.
As EIMs can occur in up to a third of UC patients, researchers aimed to assess the effect of tofacitinib, a Janus kinase inhibitor, on EIM activity during the OCTAVE studies (OCTAVE Induction 1 and 2, OCTAVE Sustain, and OCTAVE Open), which were conducted to investigate the safety and efficacy of the treatment. Changes in EIM were defined as “no change”, “worsened”, “improved”, or “new occurrence” and were determined at the end of the treatment period or when treatment was terminated.
Among patients in OCTAVE Induction 1 and 2 (N=1139), 27% (n=307) had a history of EIMS with the most frequently reported being peripheral arthritis (11.2%). Results showed that at week 8, a similar proportion of patients with active peripheral arthritis experienced no change (81.3% treated with tofacitinib 10mg twice daily vs 85.7% with placebo) or an improvement with tofacitinib (15.6% of the tofacitinib group vs 14.3% of the placebo group); worsening symptoms were observed in 3.1% of tofacitinib-treated patients. In addition, there were 6 new occurrences (5 in the tofacitinib group) of oral ulcer/stomatitis in patients who never had an EIM at baseline.
In OCTAVE SUSTAIN (N=592), 9% of patients had a history of EIMS and peripheral arthritis was again the most common (9.0%). At week 52, the majority of patients who had active peripheral arthritis at baseline experienced no change, while 2 patients treated with tofacitinib experienced improvements; worsening of symptoms was reported in 2 placebo-treated patients.
Based on their findings, the authors concluded that “longer treatment periods are required to observe more improvements in symptoms of peripheral arthritis.” They added that additional studies are needed as the “post hoc analysis of data from OCTAVE Inducton 1 and 2, and OCTAVE Sustain, was limited by low patient numbers and did not permit a conclusion on the effect of tofacitinib on EIM symptoms.”
Rubin DT, et al; Extraintestinal manifestations at baseline, and effect of tofacitinib in patients with moderate to severe ulcerative colitis in the OCTAVE program. Presented at the 2019 AIBD Annual Conference on December 12-14 in Orlando, FL.